Not yet recruiting NCT07562009
Investigation of Allergen Sensitization in Newborn Babies Diagnosed With Necrotizing Enterocolitis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: skin prick test.
- Who it may be relevant to
- Registry conditions: Necrotizing Enterocolitis, Allergy, Preterm. Basic parameters: 12 months — 24 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Allergy Risk and Sensitization Following Necrotizing Enterocolitis
Overview
To evaluate the frequency of allergy between 12 and 24 months of age in infants who were treated in the neonatal clinic and had NEC. To investigate the relationship between NEC development and the development of allergy in the later period.
Interventions
- Diagnostic test skin prick test
Skin Prick Test Procedure: The SPT was performed when patients were free of acute health problems, and medications that could affect test results had been discontinued. A histamine solution (10 mg/mL, ALK-Abelló®, Canada) was used as a positive control, and 0.9% sodium chloride was used as a negative control. The test was performed on the volar surface of the forearm, and results were read after 20 minutes. A wheal ≥3 mm greater than the negative control, with erythema, was considered positive
Primary outcome measures
- The effect of necrotizing enterocolitis development in premature infants on response to allergens. [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Infants born in our hospital and diagnosed with NEC during the study period.
- Age-matched control infants born in our hospital during the same period but without NEC diagnosis.
- Written and verbal informed consent obtained from at least one parent.
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Exclusion criteria
- Infants whose parents did not provide written or verbal consent.
- Infants with major congenital anomalies.
- Infants with chromosomal disorders.
- Infants with gastrointestinal malformations (e.g., duodenal atresia, gastroschisis, omphalocele).
- Infants diagnosed with immunodeficiency. -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07562009 · 2026-01